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FDA Issues 2013 Postmarket Surveillance Proposal

The Center for Devices and Radiological Health (CDRH) issued an update this week on its efforts towards strengthening and developing a more integrated postmarket medical device surveillance system. The recent report details a summary of planned 2013 FDA action on postmarket surveillance. While the report does incorporate some public comments from FDA's UDI draft guidance, it's not intended to substitute the final UDI guidance expected to be released next month. The anticipated final guidance release has some recently reporting new initiatives that will be combined with the UDI program. In addition, a rule to revise the medical device product labeling regulations was also proposed this week and has the potential to affect FDA's postmarket surveillance plans.

"While our current monitoring system is working well, we have proposed updates that rely in part on new technologies to collect better quality and more timely data," wrote CDRH Deputy Director for Science and Chief Scientist, William Maisel in a blog post after the publication of the report. "Not everything can be known about a device before it is marketed. That's why it's important to have a robust post-market system to collect data on how well medical devices work for patients once they have been marketed."

MDMA continues to monitor FDA's postmarket surveillance reforms and work with senior officials at FDA to ensure proper balance as new proposals are drafted and implemented.